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Old 07-23-2009, 03:07 PM   #1
Kim in DC
Senior Member
 
Join Date: Nov 2004
Posts: 190
New TDM1 arms

Missy asked if I knew of TDM1 trials in the DC metro area. Today I had treatment (I've been on since Dec) and I asked the study nurse if there were any openings. I found out that there are 2 new phase II arms opening which are not on the clinical trial site.

Arm #1- open label (everybody gets it). If you progress before the 7th cycle, they add pertuzamab. The study # is TDM4688g. Like the others, you must have been treated with some sort of Herceptin Combination for mets to qualify. Also, because there were some cardiac issues, they have to do an ekg after the first few treatments.

Arm#2- open label TDM1 and Pertuzamab from the start. Again, you must have been treated with some Herceptin combination for mets. I don't have a trial # for this one yet.

Both arms Im sure require measurable disease. They will allow previous brain mets but I think they must be stable or NED.

The last time I checked, neither of these trials were listed. You might want to contact Genentech and see if they are opening locations in your area.

They are really trying to fast track both of these medications. As a result, they are conducting additional trials.

I am doing well on this drug. If it were not for you guys I would have never known anything about it (I knew about it before my onc). I hope that I can pass this blessing on to some one else.

praying for us all
Kim
__________________
8/98 dx right breast
5/2003 tram flap right breast
8/2004 dx new primary left breast with inflammatory bc
er/pr-, her2neu+++
8/19 taxotere and herceptin
1/15/2005 Navelbine/Herceptin
4/2005 radiation and Herceptin
5/15/2005 Herceptin alone
2/12/2008 skin biopsy positive
2/14/2008 met to sternum, possibly right breast
2/27/08 Start omitarg, herceptin, taxotere trial
3/17/08 Kicked off trial because I started too close to my last herceptin
3/19 start tykerb xeloda
Right breast confirmed met
5/15/08 skin mets gone, no hypermetabolic activity in breast, sternum healing
8/24/08 scans still look good. sternum still active with scarring. No evidence of progression
10/08 Progression in sternum
12/08 Start TDM1 trial
1/09 Scans show stable
12/09 1 year on TDM1 still stable
10/10 progression in chest and liver
11/10 false positive of liver mets; tykerb and herceptin
4/11 Tykerb/Herceptin/Xgeva
4/11 Rads to Sternum
5/12/12 NED Herceptin/Zometa
3/16/19 still NED Herceptin/Zometa very 6months
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Old 07-23-2009, 03:14 PM   #2
chrisy
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Join Date: Sep 2005
Location: Central Coast, CA
Posts: 3,207
Kim, those sound like great studies! Adding pertuzumab is one more step towards the "block all the pathways" approach Dr. Hudis discussed at SABCS a couple years ago (when he uttered the "c" word)
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Chris in Scotts Valley
June 2002 extensive hi grade DCIS (pre-cancer-stage 0, clean sentinal node) Mastectomy/implant - no chemo, rads. "cured?"
9/2004 Diag: Stage IV extensive liver mets (!) ER/PR- Her2+++
10/04-3/05 Weekly Taxol/Carboplatin/Herceptin , complete response!
04/05 - 4/07 Herception every 3 wks, Continue NED
04/07 - recurrence to liver - 2 spots, starting tykerb/avastin trial
06/07 8/07 10/07 Scans show stable, continue on Tykerb/Avastin
01/08 Progression in liver
02/08 Begin (TDM1) trial
08/08 NED! It's Working! Continue on TDM1
02/09 Continue NED
02/10 Continue NED. 5/10 9/10 Scans NED 10/10 Scans NED
12/10 Scans not clear....4/11 Scans suggest progression 6/11 progression confirmed in liver
07/11 - 11/11 Herceptin/Xeloda -not working:(
12/11 Begin MM302 Phase I trial - bust:(
03/12 3rd times the charm? AKT trial

5/12 Scan shows reduction! 7/12 More reduction!!!!
8/12 Whoops...progression...trying for Perjeta/Herceptin (plus some more nasty chemo!)
9/12 Start Perjeta/Herceptin, chemo on hold due to infection/wound in leg, added on cycle 2 &3
11/12 Poops! progression in liver, Stop Perjeta/Taxo/Herc
11/12 Navelbine/Herce[ptin - try for a 3 cycles, no go.
2/13 Gemzar/Carbo/Herceptin - no go.
3/13 TACE procedure
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Old 07-23-2009, 03:25 PM   #3
Kim in DC
Senior Member
 
Join Date: Nov 2004
Posts: 190
Correction, these studies are on the clinical trial site. The first one is NCT00943670 the second is NCT00875979.

Hope that helps!
__________________
8/98 dx right breast
5/2003 tram flap right breast
8/2004 dx new primary left breast with inflammatory bc
er/pr-, her2neu+++
8/19 taxotere and herceptin
1/15/2005 Navelbine/Herceptin
4/2005 radiation and Herceptin
5/15/2005 Herceptin alone
2/12/2008 skin biopsy positive
2/14/2008 met to sternum, possibly right breast
2/27/08 Start omitarg, herceptin, taxotere trial
3/17/08 Kicked off trial because I started too close to my last herceptin
3/19 start tykerb xeloda
Right breast confirmed met
5/15/08 skin mets gone, no hypermetabolic activity in breast, sternum healing
8/24/08 scans still look good. sternum still active with scarring. No evidence of progression
10/08 Progression in sternum
12/08 Start TDM1 trial
1/09 Scans show stable
12/09 1 year on TDM1 still stable
10/10 progression in chest and liver
11/10 false positive of liver mets; tykerb and herceptin
4/11 Tykerb/Herceptin/Xgeva
4/11 Rads to Sternum
5/12/12 NED Herceptin/Zometa
3/16/19 still NED Herceptin/Zometa very 6months
Kim in DC is offline   Reply With Quote
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